Pilot Study Concerning an Intelligent Activity-based Client-centred Training System in Neurorehabilitation (i-ACT)

PXL University College

Status: Completed

Conditions: Neurological Rehabilitation; Central Nervous System Diseases

Treatments: Other: Semi-structured interview; Device: an intelligent client-centred task-oriented training

Study type: Interventional

Funder types: Other

Identifiers

NCT04692311

i-ACT pilot

Details and patient eligibility

About

The pilot study was performed to evaluate the usability, credibility and expectancy of an intelligent, activity-based client-centred training system (i-ACT), and the motivation towards its use in neurological rehabilitation over a short period of time.

Full description

A mixed-method study was performed in four rehabilitation centres in Belgium. An homogenous convenience sample was recruited among persons with central nervous system disorders.

Participants received 3 x 45 minutes of training with the i-ACT system during six weeks, additional to conventional care. The Canadian Occupational Performance Measure (COPM) was used to collect and evaluate patients' individual goals towards rehabilitation. These goals were discussed with the therapists before implementing movements and exercises for each patient in the i-ACT system.

The following demographic data were obtained from the medical files: age, gender, and diagnosis. Outcomes measures were collected at baseline (T0), after 2 (T1), 4 (T2) and 6 (T3) weeks of training and at 9 weeks follow-up (T4).

The primary outcome measures were the Intrinsic Motivation Inventory (IMI), the System Usability Scale (SUS), Credibility/Expectancy Questionnaire (CEQ), the Canadian Occupational Performance Measure (COPM), and Wolf Motor Function Test (WMFT). The secondary measures were the Manual Ability Measure-36 (MAM-36), Modified Fatigue Impact Scale (MFIS), Trunk Impairment Scale (TIS), and Active Range of Motion (AROM).

After final training with i-ACT, a semi-structured interview was performed to gather more information about the participants' perception towards i-ACT.

For quantitative data, within-group differences of all the assessments were analysed using Friedman's ANOVA and Wilcoxon signed-rank test. Alpha was set at 0.05; No Bonferroni correction was applied as it is not compulsory in an exploratory study and furthermore, results are regarded as hypothesis for further investigations.

The qualitative data was collected and recorded with a voice recorder. No specific analysis was used as the interview collected data to support or oppose the findings of the quantitative data.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18 years old
• a medical diagnosis of central nervous system disease
• dysfunction in upper limb and/or core stability
• Persons with multiple sclerosis (MS) had to be free of treatment with corticosteroids for one month.
• Persons with stroke or spinal cord injury, had to be at least three months post injury.

Exclusion criteria

• severe spasticity (when spasticity impedes movement)
• severe cognitive impairment (person is not able to understand and follow instructions)
• severe communicative impairment (person is not able to answer questions)
• severe visual impairment (person is not able to see the television screen)
• persons who use an electric wheelchair

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Persons with central nervous system diseases

Experimental group

Description:

Persons with central nervous system diseases received additional training with i-ACT during 6 weeks. After final training, a semi-structured interview was performed. And at six weeks follow-up, a final assessment took place.

Treatment:

Device: an intelligent client-centred task-oriented training

Other: Semi-structured interview

Occupational therapists

Other group

Description:

Occupational therapists were invited to a semi-structured interview to gather information about their professional opinion regarding i-ACT.

Treatment:

Other: Semi-structured interview